Claims for Patent: 10,023,917

Summary for Patent: 10,023,917

Title:	High resolution melting analysis as a prescreening tool
Abstract:	Compositions and methods for determining an increased likelihood of a response to a targeted treatment of a cancer disease including isolating genomic DNA from a patient sample, amplifying a fragment of DNA by means of PCR with a specific pair of amplification primers, determining if the amplified fragment comprises a wildtype sequence or a mutation by means of a High Resolution Melting Analysis (HRM), and correlating the presence or absence of a mutation with an increased likelihood of success of said targeted treatment. Respective primer pairs, compositions and kits are also claimed.
Inventor(s):	Buettner; Reinhard (Villiprott, DE), Froehner; Stefanie (Penzberg, DE), Merkelbach-Bruse; Sabine (Aachen, DE), Ney; Jasmin (Wallerfangen, DE), Roesler; Angelika (Sindelsdorf, DE)
Assignee:	Roche Molecular Systems, Inc. (Pleasanton, CA)
Application Number:	14/958,567
Patent Claims:	1. A method of treating a cancer patient comprising: i) isolating genomic DNA from a sample from the cancer patient; ii) amplifying a fragment of said DNA by means of PCR with a specific pair of amplification primers, thereby forming an amplified fragment; iii) determining that said amplified fragment does not comprise a G13_V14A or G60D mutation in the KRAS gene by means of a High Resolution Melting Analysis (HRM) and DNA sequencing; and iv) treating the cancer patient with an anti-EGFR targeted treatment. 2. The method of claim 1, wherein in step ii, the amplification primers comprise one or more sequences selected from the group consisting of SEQ ID NOs: 9-16. 3. The method of claim 1, wherein the sample is Formalin Fixed Paraffin Embedded (FFPE) tissue. 4. The method of claim 1, wherein said step of determining comprises performing High Resolution Melting Analysis without any spiking of DNA. 5. The method of claim 1, wherein said step of determining comprises comparing HRM analysis results of the amplified fragment to a control. 6. The method of claim 5, wherein the control comprises HRM analysis results of a wildtype sample. 7. The method of claim 1, wherein HRM is performed using a probe selected from a group consisting of SEQ ID NO: 31 or its complement, SEQ ID NO: 32 or its complement, and SEQ ID NO: 33 or its complement. 8. The method of claim 1, wherein the cancer patient has colorectal cancer. 9. The method of claim 1, wherein the anti-EGFR targeted treatment is an anti-EGFR antibody therapy. 10. The method of claim 1, wherein the anti-EGFR targeted treatment is panitumumab or cetuximab.

Details for Patent 10,023,917

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2031-01-11
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2031-01-11
Amgen, Inc.	VECTIBIX	panitumumab	Injection	125147	09/27/2006		2031-01-11